Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Altretamine and Etoposide in Treating Patients With HIV-Related Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI RPCI-DS-95-05 NCI-G97-1165, NCT00002936

Objectives

I.  Determine toxic effects of repeated courses of altretamine plus etoposide 
at the maximum tolerated dose (MTD).

II.  Assess the response duration and time to progression at the MTD in the 
treatment of HIV malignancies.

III.  Assess the efficacy of the combination on the immune systems of these 
individuals.

IV.  Assess the effect of the combination on the quality of life in these 
individuals.

Entry Criteria

Disease Characteristics:

Documented HIV antibody positive

Histologically confirmed, by biopsy, non-Hodgkin's lymphoma that is
 in complete remission or stable/partial remission for a minimal
 period of one month

And/or

Histologically confirmed, by biopsy, Kaposi's sarcoma without
 stable disease

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Patients with concurrent antiretroviral therapy should be on a
  stable dose of that therapy for at least one month prior to entry
 No concurrent cytotoxic chemotherapy

Endocrine therapy:
 No concurrent hormone therapy

Radiotherapy:
 No concurrent radiotherapy

Surgery:
 Not specified

Patient Characteristics:

Age:
 18 and over

Performance status: 
 Karnofsky 60-100%

Hematopoietic:
 Absolute neutrophil count at least 500/mm3
 Platelet count greater than 25,000/mm3 (unless secondary to lymphoma)

Hepatic:
 Transaminases less than 5 times upper limit of normal AND
 Bilirubin less than 2.0, unless secondary to lymphoma

Renal:
 Creatinine less than 2.0 mg/dL OR
 Creatinine clearance at least 60 mL/min
  Dose reduction of 21% if creatinine clearance 10-50 mL/min
  Dose reduction of 50% if creatinine clearance less than 10 mL/min

Cardiovascular:
 No active cardiac arrhythmia or angina

Pulmonary:
 Must exclude Pneumocystis carinii pneumonia if there is any
  suspicion of infection

Other:
 No uncontrolled infections 
 Not pregnant or nursing
 Adequate contraception for fertile patients
 

Expected Enrollment

20 patients will be accrued in 2 years.

Outline

Patients are treated with altretamine (HMM) and etoposide for 2 weeks followed 
by 2 weeks of rest.  This cycle is repeated for a minimum of 2 and a maximum 
of 6 cycles if there is no progression of disease.  Patients who are in 
complete remission receive an additional 2 cycles (total of 8 cycles).  

There are different cohorts consisting of 4 patients each in which toxic 
effects will be evaluated with escalating doses of this combination.  The MTD 
is defined as the dose level immediately below that at which half of the 
patients experience dose-limiting toxicity. 

Patients are followed for relapse and survival.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Lawrence Leichman, MD, Protocol chair(Contact information may not be current)		Ph: 518-262-5513

Registry Information
Official Title		Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial
Trial Start Date		1996-07-10
Registered in ClinicalTrials.gov		NCT00002936
Date Submitted to PDQ		1996-07-10
Information Last Verified		2001-04-01
NCI Grant/Contract Number		P30-CA16056

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